Catalog Number

PM030-A

Brand Name

Halyard

Version/Model Number

13537

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K051401,K051401

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Public Device Record Key

b6769094-6e0e-422b-ab13-9328ef66deb6

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

August 10, 2016

Package DI Number

30680651135378

Quantity per Package

5

Contains DI Package

10680651135374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS